Tibial Tubercule Osteotomy

ABSTRACT

Patient-specific guides for a tibial tubercle osteotomy are provided. The guides include a guide body defining a portion with a bone-engaging surface that conforms as a negative surface to a corresponding surface of a specific patient&#39;s tibia, and a guide portion that guides a surgical instrument to a specific location on the specific patient&#39;s tibia, wherein the bone-engaging surface and guide portion are configured during a pre-operative planning stage. Methods for performing a tibial tubercle osteotomy with the patient-specific guides are also provided.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

A tibial tubercle osteotomy is a surgical procedure which is performedto treat patellofemoral conditions, such as patellar instability,patellofemoral pain and chondrosis, and osteoarthritis. Such anosteotomy is typically performed when nonoperative measures, such asphysical therapy, have failed. During a tibial tubercle osteotomy anincision is made in the anterior of a patient's leg just inferior to thepatella, and a proximal and anterior portion of a tibia is partiallyresected to generate a tubercle flap. The tubercle flap is thenrepositioned in anterior and medial-lateral directions and held in placewith screws. Typically, a tibial tubercle osteotomy results inanteromedialization (AMZ) of the tubercle. This repositioning alters theposition of the patella in a patient to remove a pain-causing load,resulting in alleviation of a patellofemoral condition characterized bymalalignment of the patella relative to asymptomatic individuals.

Many tibial tubercle osteotomies are performed with the aid ofcommercially available osteotomy systems. However, these systemsgenerally comprise multiple units that are complicated to use. Moreover,the commercially available systems are mass produced, and are nottailored to a specific patient's anatomy. Therefore, there remains aneed to develop new guide systems that are easier to use than currentlyavailable systems, and that are custom manufactured to match the anatomyof a specific patient.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

The present teachings provide a patient-specific guide for a tibialosteotomy. The guide includes a guide body defining a portion with abone-engaging surface that conforms as a negative surface to acorresponding surface of a specific patient's tibia, and a guide portionthat guides a surgical instrument to a specific location on the specificpatient's tibia, wherein the bone-engaging surface and guide portion areconfigured during a pre-operative planning stage.

The present teachings also provide a patient-specific guide for a tibialosteotomy that includes a guide body defining a portion with abone-engaging surface configured during a pre-operative planning stageof a tibial osteotomy to conform as a negative surface to acorresponding surface of a specific patient's tibia; and a plurality ofapertures positioned in a straight line that defines a predeterminedangle relative to a proximal-distal axis of the specific patient's tibiathat is selected during the pre-operative planning stage of the tibialosteotomy. The plurality of apertures are configured to guide theinsertion of a plurality of pins into the tibial. The plurality ofapertures have a diameter that is larger than the diameter of the pins,which allows for the guide to be removed while leaving the pins in thetibia. The pins are used as a saw guide for resecting thespecific-patient's tibia.

The present teachings further provide for a patient-specific guide for atibial osteotomy that includes a guide body that defines: (a) a portionwith a bone-engaging surface, wherein the bone-engaging surface isconfigured during a pre-operative planning stage of a tibial osteotomyto conform as a negative surface to a corresponding surface of aspecific patient's tibia; (b) a first planar slot oriented at a firstpredetermined angle and at a first predetermined position relative to aproximal-distal axis of the specific patient's tibia that is selectedduring the pre-operative planning stage of the tibial osteotomy; (c) asecond planar slot oriented at a second predetermined angle and at asecond predetermined position relative to the proximal-distal axis ofthe specific patient's tibia that is selected during the pre-operativeplanning stage of the tibial osteotomy; and (d) a plurality ofapertures. The plurality of apertures are configured to accept pins forremoveably anchoring the guide to the specific patient's tibia.

Additionally, the present teachings provide a method for performing atibial tubercle osteotomy on a patient's tibia. The method includespositioning a patient-specific guide on the patient's tibia, wherein theguide comprises a guide body defining a portion with a bone-engagingsurface configured during a pre-operative planning stage of a tibialosteotomy to conform as a negative surface to a corresponding surface ofthe patient's tibia, and a plurality of apertures; inserting a pluralityof pins through the apertures and into the patient's tibia; removing theguide; and resecting the tibia by using the pins inserted into the tibiaas a saw guide and sawing the tibia adjacent to the pins from pin to pinto generate a tubercle flap adjacent to a resected surface of the tibia.The method also includes repositioning the tubercle flap in an anteriordirection or in both anterior and medial-lateral directions to form agap between the tubercle flap and the resected surface of the tibia; andimplanting a wedge in the gap, wherein the wedge has a predeterminedshape configured during the pre-operative planning stage and wherein thewedge is composed of a material that promotes bone in-growth.

Further, the present teachings provide a method for performing a tibialtubercle osteotomy on a patient's tibia. The method includes positioninga patient-specific guide on the patient's tibia, wherein the guideincludes: (i) a portion with a bone-engaging surface, wherein thebone-engaging surface is configured during a pre-operative planningstage of a tibial osteotomy to conform as a negative surface to acorresponding surface of a specific patient's tibia; (ii) a first planarslot oriented at a first predetermined angle and at a firstpredetermined position relative to a proximal-distal axis of thespecific patient's tibia that is selected during the pre-operativeplanning stage of the tibial osteotomy, wherein the first planar slotdefined by the guide body has a distal end and a proximal end, andwherein the guide body further defines a circular slot in communicationwith the first distal end; (iii) a second planar slot oriented at asecond predetermined angle and at a second predetermined positionrelative to the proximal-distal axis of the specific patient's tibiathat is selected during the pre-operative planning stage of the tibialosteotomy; and (iv) a plurality of apertures. The method also includesanchoring the guide to the patient's tibia by inserting pins through theapertures; inserting a drill bit through the circular slot and drillinga hole through the tibia; inserting a saw blade through the first slotand resecting a first cut from the hole to the proximal end; insertingthe saw blade through the second slot and resecting a second cut;removing the pins and the guide; and further resecting the tibia toconnect the first cut and the second cut, and to connect the second cutto a surface of the tibia to form a tubercle flap adjacent to a resectedsurface of the tibia.

The present teachings additionally provide a surgical kit that includesa patient-specific guide having a guide body defining a portion with abone-engaging surface that conforms as a negative surface to acorresponding surface of a specific patient's tibia, and a guide portionthat guides a surgical instrument to a specific location on the specificpatient's tibia, wherein the bone-engaging surface and guide portion areconfigured during a pre-operative planning stage; a patient-specificimplantable wedge with a predetermined shape, wherein the wedge isconfigured during the pre-operative planning stage; and a plurality ofpins.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a schematic illustration of a first patient-specific guidepositioned relative to a tibia;

FIG. 2 is a schematic illustration of a second embodiment of the firstpatient-specific guide positioned relative to a tibia;

FIG. 3 is a schematic illustration of the first patient-specific guidepositioned relative to the tibia, with pins inserted into the tibia;

FIG. 4 is a schematic illustration of planes cut through a tibia alongthe pins positioned with the use of the first patient-specific guide togenerate a tubercle flap;

FIG. 5 is a schematic illustration of a repositioned tubercle flapgenerated with the use of the first patient-specific guide;

FIG. 6A is a schematic illustration of a first patient-specific implant;

FIG. 6B is a schematic illustration of a second patient-specificimplant;

FIG. 7 is a schematic illustration of the patient-specific implantinserted into a gap generated in a tibia with the use of the firstpatient-specific guide;

FIG. 8 is a schematic illustration of a second patient-specific guidepositioned relative to a tibia;

FIG. 9 is a schematic illustration of planes cut through a tibia withthe use of the second patient-specific guide to generate a tubercleflap;

FIG. 10 is a schematic illustration of a repositioned tubercle flapgenerated with the use of the second patient-specific guide; and

FIG. 11 is a schematic illustration of the patient-specific implantinserted into a gap generated in a tibia with the use of the secondpatient-specific guide.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

The present teachings generally provide patient-specific tibial tubercleosteotomy guides that include a guide body defining a portion with abone-engaging surface that conforms as a negative surface to acorresponding surface of a specific patient's tibia about the patient'stibial tubercle, and a guide portion that guides a surgical instrumentto a specific location on the specific patient's tibia, wherein thebone-engaging surface and guide portion are configured during apre-operative planning stage, in which a medical professional determinesthe location of a tibial tubercle osteotomy and amount of correctionneeded. In various embodiments, the guide body further defines a softtissue engaging surface, wherein the soft tissue-engaging surface isconfigured during the pre-operative planning stage of a tibial osteotomyto conform as a negative surface to a corresponding surface of aspecific patient's soft tissue. The soft tissue can be the patient'smedial collateral ligament, lateral cruciate ligament, or patellartendon. In other embodiments, the guide body defines a surface thatallows for clearance of soft tissue.

In one embodiment, the guide portion comprises a plurality of aperturesdefined by the guide body. The plurality of apertures are configured toguide pins to the specific-patient's tibia, wherein the pins are used asa saw guide for resecting the specific-patient's tibia. The plurality ofapertures are positioned in three straight lines that define threepredetermined angles relative to a proximal-distal axis of the patient'stibia that are selected during the pre-operative planning stage of thetibial osteotomy.

In another embodiment, the guide portion comprises a first planar slotdefined by the guide body oriented at a first predetermined angle and ata first predetermined position relative to a proximal-distal axis of thespecific patient's tibia that is selected during the pre-operativeplanning stage of the tibial osteotomy; and a second planar slot definedby the guide body oriented at a second predetermined angle and at asecond predetermined position relative to the proximal-distal axis ofthe specific patient's tibia that is selected during the pre-operativeplanning stage of the tibial osteotomy. The first planar slot defined bythe guide body has a distal end and a proximal end, wherein the guidebody further defines a circular slot in communication with the firstdistal end.

The patient-specific alignment guides can be used either withconventional or patient-specific implant components prepared withcomputer-assisted image methods. Computer modeling for obtaining threedimensional images of the patient's anatomy using x-ray, MRI or CT scansof the patient's anatomy, the patient specific prosthesis components,and the patient-specific guides can be provided by various CAD programsand/or software available, for example, by Materialise USA, Plymouth,Mich. The guide will allow a surgeon to precisely cut an osteotomy,which ensures that an implant will match the native bone anatomy andprovide the proper amount of adjustment.

The patient-specific alignment guides and associated patient-specificimplants disclosed herein can be generally formed using computermodeling based on the patient's 3-D anatomic image generated from imagescans. The patient-specific alignment guides can have athree-dimensional patient-specific engagement surface that is made toconformingly contact, mate with, and match a three-dimensional image ofthe patient's bone surface (selectively with or without soft tissue), bythe computer methods discussed above. The patient-specific alignmentguides can include custom-made guiding formations, such as, for example,guiding bores or guiding apertures, cannulated guiding extensions orreceptacles that can be used for supporting or guiding otherinstruments, such as drill guides, reamers, cutters, and cutting guidesor for inserting pins or other fasteners according to a surgeon-approvedpre-operative plan.

In various embodiments, the patient-specific alignment guide can includeone or more patient-specific cutting guides for receiving and guiding acutting blade at corresponding patient-specific cutting planeorientations relative to a selected anatomic axis for the specificpatient. The patient-specific alignment guides can also include guidingformations for guiding the implantation of patient-specific oroff-the-shelf implants associated with the osteotomy procedure, such asimplantable wedges and implantable fixation plates. The geometry, shapeand orientation of the various features of the patient-specificalignment guide, as well as various patient-specific implants and otherpatient-specific tools can be determined during the pre-operativeplanning stage of the procedure in connection with the computer-assistedmodeling of the patient's anatomy. During the pre-operative planningstage, patient-specific alignment guides, implants and other tools, canbe designed and manufactured for a specific patient with input from asurgeon or other professional associated with the surgical procedure, asdescribed in U.S. Pat. No. 8,632,547, issued on Jan. 21, 2014 to Maxsonet al., U.S. Pat. No. 8,241,293, issued on Aug. 14, 2012 to Stone etal., and U.S. application Ser. No. 14/262,105 to Eash, filed on Apr. 25,2014, all of which are incorporated herein by reference.

In the following discussion, the terms “patient-specific”, “custom-made”or “customized” are defined to apply to components, including tools,implants, portions or combinations thereof, which include certaingeometric features, including surfaces, curves, or other lines, andwhich are made to closely conform as mirror-images or negatives ofcorresponding geometric features of a patient's anatomy during apre-operative planning stage based on 3-D computer images of thecorresponding anatomy reconstructed from image scans of the patient bycomputer imaging methods. Further, patient-specific guiding features,such as, guiding apertures and guiding slots, or other holes or openingsthat are included in alignment guides or in implants are defined asfeatures that are made to have positions, orientations, dimensions,shapes and/or define cutting planes specific to the particular patient'sanatomy based on the computer-assisted pre-operative plan associatedwith the patient.

The current technology provides a patient-specific tibial osteotomyguide 100 as shown in FIG. 1. The guide 100 comprises a guide body 102that defines a portion with a bone-engaging surface 103 configuredduring a pre-operative planning stage of a tibial osteotomy to conformas a negative surface to a corresponding surface of a specific patient'stibia 104. As shown in FIG. 1, the guide 100 is positioned on thespecific patient's tibia 104 about a tubercle 108 on a medial face ofthe tibia 104. In other embodiments, the guide 100 can be configured tobe positioned on a lateral face of the specific patient's tibia 104. Thebone engaging surface 103 is custom made during the pre-operativeplanning stage to match a specific patient's anatomy and allows forplacement of the guide 100 at a specific location at a proximal portion106 of the patient's tibia 104. Typically, the guide 100 is configuredto fit on and nest with only one position on the specific patient'stibia 104 at, around, or near the tubercle 108, which is to berepositioned during an osteotomy.

In some embodiments, the guide body 102 also defines a softtissue-clearing portion 109 that allows for clearance of soft tissue,such as ligaments and tendons. The soft tissue-clearing portion 109 hasan outer convex surface and an inner concave surface, wherein the innerconcave surface provides a recess for accommodating soft tissue. Asshown in FIG. 1, the soft tissue-clearing portion 109 accommodates thepatient's patellar tendon 111. However, in various embodiments, thetissue-clearing portion 109 accommodates a medial collateral ligament(MCL) 113 or a lateral cruciate ligament (LCL, not shown). In thisregard, the bone-engaging surface 103 mates with and conforms to aspecific boney region of the tibia 104, and the patellar softtissue-clearing portion 109 allows for the guide to simultaneously beplaced about the patient's soft tissue, such as the patellar tendon 111.In other embodiments, the guide 100 comprises a plurality oftissue-clearing portions 109 for simultaneously accommodating the LCLand patellar tendon, or MCL and patellar tendon.

In additional embodiments, the guide body 102 further defines a softtissue engaging surface 109′, wherein the soft tissue-engaging surface109′ is configured during the pre-operative planning stage of a tibialosteotomy to conform as a negative surface to a corresponding surface ofa specific patient's soft tissue at, around, or near the tubercle 108.The soft tissue can be, for example, the patient's MCL, LCL, or patellartendon. In various embodiments, the guide 100 comprises a plurality ofsoft tissue engaging surfaces 109′ for simultaneously accommodating theLCL and patellar tendon, or MCL and patellar tendon. In otherembodiments, the guide 100 has both a soft tissue-clearing portion 109and a soft tissue engaging surface 109′.

The guide body 102 further defines a first plurality of apertures 110positioned along a first straight line 112 that defines a firstpredetermined angle θ₁ relative to a proximal-distal axis 114 of thespecific patient's tibia 104. The first straight line 112 is selectedduring the pre-operative planning stage of the tibial osteotomy. In manyembodiments, a second plurality of apertures 116 is positioned along asecond straight line 118 that defines a second predetermined angle θ₂relative to the proximal-distal axis 114 of the specific patient's tibia104 that is selected during the pre-operative planning stage of thetibial osteotomy, wherein the second line 118 intersects the first line112. In yet other embodiments, a third plurality of apertures 120 ispositioned along a third straight line 122 that defines a thirdpredetermined angle θ₃ relative to the proximal-distal axis 114 of thespecific patient's tibia 104 that is selected during the pre-operativeplanning stage of the tibial osteotomy, wherein the third line 122intersects the second line 118.

The first, second, and third plurality of apertures 110, 116, 120 areconfigured to guide a plurality of pins 124 to the tibia 104 forinsertion. The plurality of apertures 110, 116, 120 have a diameter D₁and the pins 124 have a diameter D₂, wherein D₁ is larger than D₂.Because the apertures 110, 116, 120 have a larger diameter than the pins124, the guide 100 can be removed from the tibia 104 by simply slidingthe guide 100 off from the implanted pins 124. When the guide 100 isremoved, the pins 124 provide a saw guide for resecting planes in thetibia 104 adjacent to the pins 124, from pin 124 to pin 124, to generatea tubercle flap 132 as shown in FIGS. 3, 4, and 6. Accordingly, the sawguide is adjacent to the pins 124 and matches the lines 112, 118, 122,configured during the preoperative planning stage. In other words, thepins 124 give visual indicia to a physician for making threeintersecting planar cuts through the tibia 104.

As shown in FIG. 2, in various embodiments, the present technologyprovides for a bifurcated patient-specific alignment guide 150comprising a first guide half 150 a removeably coupled to a second guidehalf 150 b at a seam 152. The first half of the bifurcatedpatient-specific alignment guide 150 a has similar features as thealignment guide 100 shown in FIGS. 1 and 3, such as a plurality ofapertures 110, 116, 120 for guiding a plurality of pins 124 to the tibia104. Optionally, the second half of the guide 150 b can also have aplurality of apertures 110′, 116′, and 120′ for guiding pins 124 to thetibia 104. The bifurcated guide 150 has at least one bone-engagingsurface 154 that nests with and conforms to a boney structure. The boneystructure can be a structure on the tibia 104 or on the fibula 105. Inother embodiments, the bifurcated guide 150 has at least one soft tissueengaging surface 156 that either nests with and conforms to or providesclearance for at least one soft tissue, such as a soft tissue selectedfrom the group consisting of the patient's MCL 113, LCL 115, patellartendon 111, and combinations thereof. In yet other embodiments, thebifurcated guide 150 has both at least one bone-engaging surface 154 andat least one soft tissue-engaging surface 156. The second guide half 150b allows for the guide 150 to nest with and conform to more boneystructures and/or soft tissue structures than a guide that does notcomprise two halves. After the pins 124 have been positioned into thetibia 104, the bifurcated guide 150 can be separated at the seam 152,which permits both the first half 150 a and the second half 150 b toslide over the pins 124 and away from the tibia 104. With reference toFIG. 6A, the present technology provides a patient-specific implant orwedge 200 a that is configured during a pre-operative planning stage ofa tibial tubercle osteotomy to be wedged in a gap generated from aresection guided by the patient-specific guide 100 to maintain theposition of a patient's tibial tubercle 108 relative to the tibia 104.The patient-specific implant 200 comprises a first portion 202 that hasa first surface 204 that corresponds to the line 112 shown in FIG. 1.Because the first surface 204 corresponds to the line 112, the implant200 a is custom designed to fit in a gap generated from a resectionguided by the patient specific guide 100. In some embodiments, theimplant 200 a further comprises an optional second portion 206 that hasa second surface 208 that corresponds to the line 118 shown in FIG. 1.Because the first surface 204 corresponds to the line 112, and becausethe second surface 208 corresponds to the line 118, the implant 200 awith first and second portions 202, 206 is custom designed to fit in agap generated from a resection guided by the patient specific guide 100.In yet other embodiments, the implant 200 a further comprises anoptional third portion 210 that has a third surface 212 that correspondsto the line 122 shown in FIG. 1. Because the first surface 204corresponds to the line 112, the second surface 208 corresponds to theline 118, and the third surface 212 corresponds to the line 122, theimplant 200 a with first, second and third portions 202, 206, 210 iscustom designed to fit in a gap generated from a resection guide by thepatient specific guide 100. The patient-specific implant can be composedof a material that promotes bone in-growth. FIG. 6B is a secondpatient-specific implant 200 b that is similar to the implant 200 a.However, the second implant 200 b further comprises a substantiallyspherical portion 214 coupled to the first portion 202. The sphericalportion 214 is designed to fit in a hinge bore or a stress relief hole,as described further below.

With reference to FIG. 1, the present technology provides a method forperforming a tibial tubercle osteotomy on a patient's tibia 104 with thepatient-specific alignment guide 100. The method comprises positioningthe patient-specific guide 100 on the patient's tibia 104 at, near, oraround the tubercle 108, wherein the guide 100 comprises a guide body102 defining a portion with a bone-engaging surface configured during apre-operative planning stage of a tibial osteotomy to conform as anegative surface to a corresponding surface of the patient's tibia 104,and a first plurality of apertures 110 along line 112. As describedabove, in some embodiments, the guide body 102 further defines a secondplurality of apertures 116 along line 118 and a third plurality ofapertures 120 along line 122. Accordingly, the apertures 110, 116, 120are positioned in three intersecting straight lines 112, 118, 122 thatdefine three predetermined angles θ₁, θ₂, θ₃ relative to aproximal-distal axis 114 of the patient's tibia 104 that are selectedduring the pre-operative planning stage of the tibial osteotomy. Theguide 100 is custom made to mate with and conform to the specificpatient's tibia 104, at a proximal end 106 at or near the tubercle 108.The method also includes inserting a plurality of pins 124 through thefirst plurality of apertures 110, and into the optional second and thirdplurality of apertures 116, 120, and into the patient's tibia 104. FIG.3 shows the guide 100 positioned on the specific-patient's tibia 104,wherein pins 124 10 have been placed through the first, second, andthird plurality of apertures 110, 116, 120 and into the tibia 104.

After the pins 124 have been inserted into the tibia 104, the methodcomprises removing the guide 100 from the tibia 104. Because thediameter D₁ of the apertures 110, 116, 120 is larger than the diameterD₂ of the pins 124, the guide 100 can be removed by simply sliding theguide 100 over the pines 124.

With reference to FIG. 4, when the pins 124 are inserted into the tibia104, and the guide 100 has been removed, the method comprises resectinga first plane 126 into the tibia 104 adjacent to the pins 124 that arein line with the first line 112. Optionally, a bore, such as a hingebore or a stress relief hole, can be drilled into the tibia 104 adjacentto the most distal pin 124, wherein the first plane 126 is resected fromthe bore to the most proximal pin 124 adjacent to the first line 112.Therefore, the pins 124 provide a saw guide for resecting the firstplane 126 in the tibia 104 adjacent to the pins 124, from pin 124 to pin124. Likewise, resecting further comprises resecting a second plane 128into the tibia 104 adjacent to the pins 124 that are in line with thesecond line 118, and resecting a third plane 130 into the tibia 104adjacent to the pins 124 that are in line with the third line 122.Resecting is performed, for example, with an oscillating saw. When allthree planes 126, 128, 130 have been resected, a tubercle flap 132 isgenerated. Accordingly, the planes 126, 128, 130 resected into the tibia104 are adjacent to and match the lines 112, 118, 122 configured duringthe preoperative planning stage.

As shown in FIG. 5, after resecting, the method comprises removing thepins 124 from the tibia 104. When the pins 124 are removed, holes 134remain in the tibia 104. After the tubercle flap 132 has been generated,the method comprises repositioning the tubercle flap 132 in an anteriordirection or in both anterior and medial-lateral directions to form agap 136 between the tubercle flap 132 and the and three resectedsurfaces 138, 140, 142 of the tibia 138. Repositioning the tubercle flap132 alters the position of the patient's patella to remove apain-causing load and results in alleviation of a patellofemoralcondition characterized by malalignment of the patella relative toasymptomatic individuals. The tubercle flap 132 is repositioned to alocation predetermined during the pre-operative planning stage. Afterrepositioning the tubercle flap 132 the method comprises implanting orpositioning a patient specific implant or wedge 200 a implant gap 136,as shown in FIGS. 6A and 7. In embodiments where a hinge bore or astress relief is drilled into the tibia 104, the implant or wedge 200 bshown in FIG. 6B is utilized. As described above, the patient-specificimplant 200 a has a predetermined shape configured during thepre-operative planning stage. The implant 200 a comprises a firstportion 202, and optionally a second portion 206 or a second 206 andthird portion 210. In some embodiments, the patient-specific implant iscomposes of a material that promote bone in-growth. In an alternativemethod, the implant is an off-the-shelf, i.e., non-patient-specific,implantable wedge. Optionally, the method comprises securing thetubercle flap 132 by driving a screw through the tubercle flap 132 andthe wedge 200 a, and into the tibia 104 through one of the resectedsurfaces 138, 140, 142. The wedge 200 a maintains the position of therepositioned tubercle flap 132 and prevents the tubercle flap 132 fromreverting to its original location.

The current technology provides another patient-specific tibialosteotomy guide 300 as shown in FIG. 8. The guide 300 comprises a guidebody 302 that defines a portion with a bone-engaging surface 303configured during a pre-operative planning stage of a tibial osteotomyto conform as a negative surface to a corresponding surface of aspecific patient's tibia 104. As shown in FIG. 8, the guide 300 ispositioned on the specific patient's tibia 104 about a tubercle 108 on amedial face of the tibia 104. In other embodiments, the guide 300 can beconfigured to be positioned on a lateral face of the specific patient'stibia 104. The bone engaging surface 303 is custom made during thepre-operative planning stage to match a specific patient's anatomy andallows for placement of the guide 300 at a specific location, and inonly one position, at a proximal portion 106 of the patient's tibia 104.Typically, the guide 300 is configured to fit on a specific patient'stibia 104 at, around, or near the tubercle 108, which is to berepositioned during an osteotomy.

In some embodiments, the guide body 302 also defines a softtissue-clearing portion 309 that allows for clearance of soft tissue,such as ligaments and tendons. The soft tissue-clearing portion 309 hasan outer convex surface and an inner concave surface, wherein the innerconcave surface provides a recess for accommodating soft tissue. Asshown in FIG. 8, the soft tissue-clearing portion 309 accommodates thepatient's patellar tendon 111. However, in various embodiments, thetissue-clearing portion 309 accommodates a medial collateral ligament(MCL) 113 or a lateral cruciate ligament (LCL, not shown). In thisregard, the bone-engaging surface 303 mates with and conforms to aspecific boney region of the tibia 104, and the patellar softtissue-clearing portion 309 allows for the guide to simultaneously beplaced about the patient's soft tissue, such as the patellar tendon 111.In other embodiments, the guide 300 comprises a plurality oftissue-clearing portions 309 for simultaneously accommodating the LCLand patellar tendon, or MCL and patellar tendon.

In additional embodiments, the guide body 302 further defines a softtissue engaging surface 309′, wherein the soft tissue-engaging surface309′ is configured during the pre-operative planning stage of a tibialosteotomy to conform as a negative surface to a corresponding surface ofa specific patient's soft tissue at, around, or near the tubercle 108.The soft tissue can be, for example, the patient's MCL, LCL, or patellartendon. In various embodiments, the guide 300 comprises a plurality ofsoft tissue engaging surfaces 309′ for simultaneously accommodating theLCL and patellar tendon, or MCL and patellar tendon. In otherembodiments, the guide 300 has both a soft tissue-clearing portion 309and a soft tissue engaging surface 309′.

The guide body 302 further defines a first planar slot 304 positionedalong a fourth straight line 306 that defines a fourth predeterminedangle θ₄ relative to a proximal-distal axis 114 of the specificpatient's tibia 104. The fourth straight line 306 is selected during thepre-operative planning stage of the tibial osteotomy. Therefore, thefirst planar slot 304 is oriented at a fourth predetermined angle θ₄ andat a first predetermined position relative to a proximal-distal axis 114of the specific patient's tibia 104 that is selected during thepre-operative planning stage of the tibial osteotomy. The first planarslot 304 defined by the guide body 302 has a distal end 308 and aproximal end 310, wherein the guide body 302 further defines a circularslot 312 in communication with the first distal end 308.

Additionally, the guide body 302 defines a second planar slot 314positioned along a fifth straight line 316 that defines a fifthpredetermined angle θ₅ relative to a proximal-distal axis 114 of thespecific patient's tibia 104. The fifth straight line 316 is selectedduring the pre-operative planning stage of the tibial osteotomy.Therefore, the second planar slot 314 is oriented at a fifthpredetermined angle θ₅ and at a second predetermined position relativeto a proximal-distal axis 114 of the specific patient's tibia 104 thatis selected during the pre-operative planning stage of the tibialosteotomy

Additionally, the guide body 302 defines a third planar slot 315positioned along a fifth straight line 317 that defines a sixthpredetermined angle θ₆ relative to a proximal-distal axis 114 of thespecific patient's tibia 104. The sixth straight line 317 is selectedduring the pre-operative planning stage of the tibial osteotomy.Therefore, the third planar slot 315 is oriented at a sixthpredetermined angle θ₆ and at a third predetermined position relative toa proximal-distal axis 114 of the specific patient's tibia 104 that isselected during the pre-operative planning stage of the tibial osteotomy

The guide body 302 of the patient specific guide 300 also defines aplurality of apertures 318 for removeably anchoring the guide 300 to thespecific patient's tibia 104. The apertures have a diameter D₃ and thepins have a diameter D₄, wherein D₃ is smaller than D₄. Because theapertures 318 have a smaller diameter than the pins 320, the guide 300can be attached to the tibia 104 by way inserting the pins 320 throughthe apertures 318 and into the tibia 104. To remove the guide 300 fromthe tibia 104, the pins 320 must first be removed.

The present technology also provides a method for performing a tibialtubercle osteotomy on a patient's tibia with the use of thepatient-specific guide 300. As shown in FIG. 8, the method comprisesanchoring the guide 300 to the patient's tibia 104 by inserting pins 320through the apertures 318 and into the tibia 104. When the guide 300 isanchored in place, the method comprises inserting a drill bit throughthe circular slot 312 and drilling a circular hinge bore or stressrelief hole 322 through the tibia 104.

After drilling, the method comprises inserting a saw blade through thefirst slot 304 and resecting a first plane 324 from the bore 322 to theproximal end 310 of the first slot 304. Likewise, the method comprisesinserting the saw blade through the second slot 314 and resecting asecond plane 326 and inserting the saw blade through the third slot 315and resecting a third plane 328. Resecting can be performed, forexample, with an oscillating saw. After the planes 324, 326, 328 havebeen resected through the tibia 104 via the slots 304, 314, 315 in theguide 300, the method comprises removing the pins 320 from the tibia104, which exposes pin holes 321, and subsequently removing the guide300. As shown in FIG. 9, after the guide 300 has been removed, themethod comprises resecting the tibia 104 to connect the first plane 324to the second plane 326, the second plane 326 to the third plane 328,and the third plane 328 to an anterior surface of the tibia 104 proximalto the tubercle 108 to form a tubercle flap 330 adjacent to a resectedsurface of the tibia.

As shown in FIG. 10, after the tubercle flap 330 has been generated, themethod comprises repositioning the tubercle flap 330 in an anteriordirection or in both anterior and medial-lateral directions to form agap 338 between the tubercle flap 330 and three resected surfaces 332,334, 336 of the tibia 104. The hinge bore or stress relief hole 322ensures that repositioning the tubercle flap 330 does not crack orsplinter the tibia 104. The tubercle flap 330 is repositioned to alocation predetermined during the pre-operative planning stage.Repositioning the tubercle flap 132 alters the position of the patient'spatella remove a pain-causing load and results in alleviation of apatellofemoral condition characterized by malalignment of the patellarelative to asymptomatic individuals. After repositioning the tubercleflap 330 the method comprises implanting or positioning a patientspecific implant or wedge 200 a, 200 b in gap 338, as shown in FIGS. 6A,6B, and 11. As described above, the patient-specific implant 200 a, 200b has a predetermined shape configured during the pre-operative planningstage. The implant 200 a, 200 b comprises a first portion 202, andoptionally a second portion 206 or a second 206 and third portion 210.In some embodiments, the patient-specific implant 200 a, 200 b iscomposed of a material that promotes bone in-growth. When the secondimplant 200 b is used, the spherical portion 214 is positioned in thestress relief hole 322. In an alternative method, the implant is anoff-the-shelf, i.e., non-patient-specific, implantable wedge.Optionally, the method comprises securing the tubercle flap 330 bydriving a screw 340 through the tubercle flap 330 and the wedge 200 a,200 b, and into the tibia 104 through one of the resected surface 332.The wedge 200 a, 200 b maintains the position of the repositionedtubercle flap 330 relative to the tibia 104 and prevents the tubercleflap 330 from reverting to its original location.

The present technology additionally provides for a surgical kit or asystem for a tibial osteotomy comprising a patient-specific guidecomprising a guide body defining a portion with a bone-engaging surfacethat conforms as a negative surface to a corresponding surface of aspecific patient's tibia, and a guide portion that guides a surgicalinstrument to a specific location on the specific patient's tibia,wherein the bone-engaging surface and guide portion are configuredduring a pre-operative planning stage; a patient-specific implantablewedge with a predetermined shape, wherein the wedge is configured duringthe pre-operative planning stage; and a plurality of pins.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

What is claimed is:
 1. A patient-specific system for a tibial osteotomy,comprising: a patient specific guide comprising a guide body defining abone-engaging portion with a bone-engaging surface that conforms as anegative surface to a corresponding surface of a specific patient'stibia, and a guide portion that guides a surgical instrument to aspecific location on the specific patient's tibia, wherein thebone-engaging surface and guide portion are configured during apre-operative planning stage; a patient-specific implantable wedge witha predetermined shape, wherein the wedge is configured during thepre-operative planning stage; and a plurality of pins.
 2. Thepatient-specific system according to claim 1, wherein the guide portioncomprises a plurality of apertures defined by the guide body, whereinthe plurality of apertures are configured to guide pins to thespecific-patient's tibia, wherein the pins are used as a saw guide forresecting the specific-patient's tibia.
 3. The patient-specific systemaccording to claim 2, wherein the apertures are positioned in threestraight lines that define three predetermined angles relative to aproximal-distal axis of the patient's tibia that are selected during thepre-operative planning stage of the tibial osteotomy.
 4. Thepatient-specific system according to claim 1, wherein the guide portioncomprises: a first planar slot defined by the guide body oriented at afirst predetermined angle and at a first predetermined position relativeto a proximal-distal axis of the specific patient's tibia that isselected during the pre-operative planning stage of the tibialosteotomy; and a second planar slot defined by the guide body orientedat a second predetermined angle and at a second predetermined positionrelative to the proximal-distal axis of the specific patient's tibiathat is selected during the pre-operative planning stage of the tibialosteotomy.
 5. The patient-specific system according to claim 4, whereinthe first planar slot defined by the guide body has a distal end and aproximal end, and wherein the guide body further defines a circular slotin communication with the first distal end.
 6. The patient-specificsystem according to claim 1, wherein the guide body further defines asoft tissue-engaging surface, wherein the soft tissue-engaging surfaceis configured during the pre-operative planning stage of a tibialosteotomy to conform as a negative surface to a corresponding surface ofa specific patient's medial collateral ligament, lateral cruciateligament, or patellar tendon.
 7. A patient-specific system for a tibialosteotomy, comprising: a patient-specific guide comprising a guide bodydefining, a bone-engaging portion with a bone-engaging surfaceconfigured during a pre-operative planning stage of a tibial osteotomyto conform as a negative surface to a corresponding surface of aspecific patient's tibia at, around, or near the patient's tibialtubercle; and a first plurality of apertures positioned along a firststraight line that defines a first predetermined angle relative to aproximal-distal axis of the specific patient's tibia that is selectedduring the pre-operative planning stage of the tibial osteotomy.
 8. Thepatient-specific system according to claim 7, wherein the plurality ofapertures are configured to guide the insertion of a plurality of pinsin the tibia.
 9. The patient-specific system according to claim 7,wherein the plurality of apertures have a diameter that is larger thanthe diameter of the pins.
 10. The patient-specific system according toclaim 7, further comprising a second plurality of apertures positionedalong a second straight line that defines a second predetermined anglerelative to the proximal-distal axis of the specific patient's tibiathat is selected during the pre-operative planning stage of the tibialosteotomy, wherein the second line intersects the first line.
 11. Thepatient-specific system according to claim 10, further comprising athird plurality of apertures positioned along a third straight line thatdefines a third predetermined angle relative to the proximal-distal axisof the specific patient's tibia that is selected during thepre-operative planning stage of the tibial osteotomy, wherein the thirdline intersects the second line.
 12. The patient-specific systemaccording to claim 7, wherein the guide body further defines a softtissue-engaging surface, wherein the soft tissue-engaging surface isconfigured during the pre-operative planning stage of a tibial osteotomyto conform as a negative surface to a corresponding surface of aspecific patient's soft tissue at or about the tubercle.
 13. Thepatient-specific system according to claim 12, wherein the specificpatient's soft tissue is the patient's medial collateral ligament,lateral cruciate ligament, or patellar tendon.
 14. The patient-specificsystem according to claim 7, wherein the guide body further defines asoft tissue-clearing portion comprising an outer convex surface and aninner concave surface, wherein the inner concave surface provides arecess for accommodating the patient's medial collateral ligament,lateral cruciate ligament, or patellar tendon.
 15. The patient-specificsystem according to claim 7, wherein the guide, by way of thebone-engaging portion with the bone-engaging surface, mates with andconforms to only one specific location on the specific patient's tibiaat, around, or near the tubercle.
 16. A patient-specific system for atibial osteotomy, comprising: a patient-specific guide comprising aguide body defining, a bone-engaging portion with a bone-engagingsurface, wherein the bone-engaging surface is configured during apre-operative planning stage of a tibial osteotomy to conform as anegative surface to a corresponding surface of a specific patient'stibia at, around, or near the patient's tibial tubercle; a first planarslot oriented at a first predetermined angle and at a firstpredetermined position relative to a proximal-distal axis of thespecific patient's tibia that is selected during the pre-operativeplanning stage of the tibial osteotomy; a second planar slot oriented ata second predetermined angle and at a second predetermined positionrelative to the proximal-distal axis of the specific patient's tibiathat is selected during the pre-operative planning stage of the tibialosteotomy; and a plurality of apertures.
 17. The patient-specific systemaccording to claim 16, wherein the first planar slot defined by theguide body has a distal end and a proximal end, and wherein the guidebody further defines a circular slot in communication with the firstdistal end.
 18. The patient-specific system according to claim 16,wherein the plurality of apertures are configured to accept pins forremoveably anchoring the guide to the specific patient's tibia at asingle location near the patient's tibial tubercle.
 19. Thepatient-specific system according to claim 16, wherein the guide bodyfurther defines a soft tissue-engaging surface, wherein the softtissue-engaging surface is configured during the pre-operative planningstage of a tibial osteotomy to conform as a negative surface to acorresponding surface of a specific patient's soft tissue at or aboutthe tubercle.
 20. The patient-specific system according to claim 19,wherein the specific patient's soft tissue is the patient's medialcollateral ligament, lateral cruciate ligament, or patellar tendon. 21.The patient-specific system according to claim 16, wherein the guidebody further defines a soft tissue-clearing portion comprising an outerconvex surface and an inner concave surface, wherein the inner concavesurface provides a recess for accommodating the patient's medialcollateral ligament, lateral cruciate ligament, or patellar tendon. 22.A method for performing a tibial tubercle osteotomy on a patient'stibia, comprising: positioning a patient-specific guide on the patient'stibia, wherein the guide comprises a guide body defining a bone-engagingportion with a bone-engaging surface configured during a pre-operativeplanning stage of a tibial osteotomy to conform as a negative surface toa corresponding surface of the patient's tibia at, around or near thetubercle of the patient's tibia, and a plurality of apertures; resectingthe tibia in three intersecting planes with a saw to generate a tubercleflap, wherein the patient-specific guide provides visual indicia forresecting; and repositioning the tubercle flap in an anterior directionor in both anterior and medial-lateral directions to form a gap betweenthe tubercle flap and the resected surface of the tibia.
 23. The methodaccording to claim 22, further comprising implanting a wedge in the gap,wherein the wedge has a predetermined shape configured during thepre-operative planning stage and wherein the wedge is composed of amaterial that promotes bone in-growth.
 24. The method according to claim23, further comprising securing the tubercle flap relative to theresected surface of the tibia by driving a screw through the tubercleflap and the wedge, and into the tibia through the resected surface. 25.The method according to claim 22, wherein the plurality of apertures arepositioned along three intersecting lines that define threepredetermined angles relative to a proximal-distal axis of the patient'stibia that are selected during the pre-operative planning stage of thetibial osteotomy, and wherein the method further comprises: inserting aplurality of pins through the apertures, the pins having a diametersmaller than a diameter of the apertures; and removing the patientspecific guide, wherein the pins provide the visual indicia forresecting.
 26. The method according to claim 22, wherein the guide bodyfurther defines a first planar slot oriented at a first predeterminedangle and at a first predetermined position relative to aproximal-distal axis of the specific patient's tibia that is selectedduring the pre-operative planning stage of the tibial osteotomy, whereinthe first planar slot defined by the guide body has a distal end and aproximal end, the guide body further defining a circular slot incommunication with the first distal end, and wherein the method furthercomprises: anchoring the guide to the patient's tibia near the tubercleby inserting pins through the apertures and into the tibia; inserting adrill bit through the circular slot and drilling a hole through thetibia; resecting a first plane through the tibia by inserting a sawblade through the first slot; resecting a second plane through the tibiaby inserting a saw blade through the second slot; removing the pins andthe guide; further resecting the tibia to connect the first plane andthe second plane; and resecting a third plane through the tibia toconnect the second plane to an anterior surface of the tibia to form thetubercle flap.
 27. The method according to claim 22, wherein the guidebody further defines a soft tissue-clearing portion comprising an outerconvex surface and an inner concave surface, and wherein positioning thepatient-specific guide on the patient's tibia further comprises nestingthe bone-engaging surface of the guide onto a corresponding surface onthe tibia, wherein the inner concave surface of the soft tissue-clearingportion provides a recess for accommodating the patient's medialcollateral ligament, lateral cruciate ligament, or patellar tendon